NCT00016393已完成2 期
A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 55
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer.
- Determine the overall survival and progression-free survival rate in patients treated with this drug.
- Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug.
- Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1)
- •Unresponsive or refractory to prior hormonal therapy by at least 1 of the following:
- •Progression of unidimensionally measurable lesion outside of a prior radiation port
- •Progression of non-measurable disease (e.g., bone scan)
- •Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart
- •PSA at least 5 ng/mL
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •SGOT or SGPT no greater than 2.5 times ULN
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 40 mL/min
- •No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission
- •No other concurrent significant active illness that would preclude study participation
- •Recovered from major infections
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 28 days since prior biologic therapy and recovered
- •No more than 1 prior biologic (non-cytotoxic) therapy
- •No concurrent biological response modifiers
- •Chemotherapy:
- •No prior chemotherapy for this disease
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •At least 28 days since prior flutamide or ketoconazole
- •At least 42 days since prior bicalutamide or nilutamide
- •No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy
- •No concurrent corticosteroids
- •Radiotherapy:
- •See Disease Characteristics
- •Prior radiotherapy to less than 30% of bone marrow allowed
- •No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
- •At least 28 days since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •Recovered from prior surgery
- •Prior orchiectomy allowed
- •No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer)
- •Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)
排除标准
- 未提供
研究者
研究点 (55)
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